Evaluation of Topical Citrullus Colocynthis Fruit Oil Efficacy in Treatment of Painful Peripheral Diabetic Neuropathy

November 14, 2014 updated by: Mesbah Shams, MD, Shiraz University of Medical Sciences
This study is designed to evaluate the topical Citrullus colocynthis fruit oil efficacy in treatment of painful peripheral diabetic neuropathy (PDN) in a randomized double blind placebo-controlled clinical trial design. This study includes 60 patients from SUMS endocrinology and diabetes clinic. Patients with painful conditions other than PDN such as radiculopathies will be excluded. After giving the Informed consent the patients will be underwent NCS (Nerve Conduction Study) for confirming the diagnosis before recruitment. They will be followed for 12 weeks and after 12 weeks the outcome measures including Neuropathic Pain Scale (NPS), WHOQOL-BREF (World Health Organisation Quality of Life Brief) questionnaire and electrodiagnostic criteria will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Fars
      • Shiraz, Fars, Iran, Islamic Republic of
        • Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences
      • Shiraz, Fars, Iran, Islamic Republic of
        • Department of Physical Medicine and Rehabilitation - Shiraz University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Controlled type 1 or 2 diabetes mellitus
  • Painful Peripheral diabetic neuropathy for more than 3 months
  • Age more than 18 years old
  • Patients consent on enrolling study and admitting study protocol

Exclusion criteria:

  • Other causes of pain in lower extremities like lumbar disk herniation
  • Ulcerative lesions in lower extremities
  • Dermatitis
  • Pregnancy
  • Lactation
  • Citrullus colocynthis allergy
  • Unstable cardiac, neurological or renal disease
  • Diagnosed other types of neuropathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Topical Citrullus colocynthis fruit oil
Topical Citrullus colocynthis fruit oil (1%) 1 cc twice daily
Drug: Topical Citrullus colocynthis fruit oil (1%)
Placebo Comparator: Placebo (Vehicle)
Topical vehicle oil 1 cc twice daily
Drug: Topical vehicle oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain Scores on the Neuropathic Pain Scale (NPS)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
WHOQOL-BREF Score
Time Frame: 12 weeks
12 weeks
Number of Participants with Adverse Events
Time Frame: 12 weeks
12 weeks
Nerve Conduction Velocity (NCV) (m/sec) of common peroneal nerve (CPN)
Time Frame: 12 weeks
12 weeks
NCV (m/sec) of tibial nerve
Time Frame: 12 weeks
12 weeks
Distal latency (millisecond) of superficial peroneal nerve (SPN)
Time Frame: 12 weeks
12 weeks
Distal latency (millisecond) of sural nerve
Time Frame: 12 weeks
12 weeks
Sensory amplitude (microvolt) of SPN
Time Frame: 12 weeks
12 weeks
Sensory amplitude (microvolt) of sural nerve
Time Frame: 12 weeks
12 weeks
Motor amplitude (microvolt) of CPN
Time Frame: 12 weeks
12 weeks
Motor amplitude (microvolt) of tibial nerve
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Investigators

  • Study Chair: Mesbah Shams, M.D., Research Center for Traditional Medicine & History of Medicine - Shiraz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 31, 2014

First Submitted That Met QC Criteria

June 2, 2014

First Posted (Estimate)

June 4, 2014

Study Record Updates

Last Update Posted (Estimate)

November 17, 2014

Last Update Submitted That Met QC Criteria

November 14, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-9377-7007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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